Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Hematoma (1884); Failure of Implant (1924)
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Event Date 01/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 - medical devices: unk femoral biomet oxford twin pegged cementless sz.M; item# unknown, lot# unknown.Unk tibia biomet oxford medial cementless sz.D; item# unknown, lot# unknown.H3 - product was discarded.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Product is unknown.
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Event Description
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It was reported that a patient had undergone left unicompartmental knee surgery.Subsequently, the patient developed a hematoma, which was successfully resolved with the use of compression wraps.Additionally, the patient underwent a revision surgery to repair a capsular defect that occurred after kneeling on the operated knee.A poly exchange was performed, and no additional information was provided.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the complaint is a duplicate of (b)(4).Given this information, this medwatch will be voided.
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Event Description
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Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the complaint is a duplicate of (b)(4)- mdr report number 3002806535-2019-00104 - mdr report number 3002806535-2019-00104.Given this information, this medwatch will be voided.
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Search Alerts/Recalls
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